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Effects of Sub-Occipital Myofascial Release in Patients With Cervicogenic Headache

Primary Purpose

Cervicogenic Headache

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
cervical mobilization (Headache SNAG)
Sub-occipital myofascial release
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headache focused on measuring Cervicogenic headache, Pain Numerical Rating Scale, Neck disability index

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Both Genders

    • Age between 20 to 75 Years
    • Neck pain referring the unilateral pain to the sub-occipital region and head.
    • Headache intensifying upon manual pressure to upper cervical joints and muscles
    • With the cranio-cervical Flexion rotation exam, neck pain and ipsilateral headache and restriction of C1 and C2 rotation.

Exclusion Criteria:

  • • Tension headache (Headache on both sides)

    • If the patient not tolerate the cranio-cervical Flexion rotation test.
    • Patients presents with autonomic symptoms like visual disturbance, vertigo, dizziness.
    • If the physiotherapeutic modalities used for head pain in the last 6 months.
    • Headache other than cervical origins.
    • Clinically diagnosed as case of cervical radiculopathy or myelopathy.
    • Extreme cervical discomfort due to disk herniation, stenosis of the spinal canal and cervical arthritis.
    • Each other disorder that may be contraindicated in the upper cervical area of myofascial release.

Sites / Locations

  • Riphah Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Studygroup

Control Group

Arm Description

cervical mobilization (Headache SNAG) with baseline treatment (Hot pack for 10 minutes, TENS 10 minutes, Neck isometrics and stretching).

Sub-occipital myofascial release with baseline treatment (Hot pack for 10 minutes, TENS for 10 minutes, Neck isometrics and stretching

Outcomes

Primary Outcome Measures

Pain Numeric Rating Scale
Pain Numeric Rating Scale (PNRS) scores in subjects with moderate/severe pain at baseline. *P < 0.0001 vs. baseline. Includes only subjects with baseline PNRS score of 4 to 10. Scale ranges from 0 to 10.
NECK DISABILITY INDEX
the overall score range is between 0 and 50, 0 being no to little pain and discomfort while 50 being the severest degree of pain and disability with complete activity limitation.

Secondary Outcome Measures

Full Information

First Posted
March 24, 2021
Last Updated
August 27, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04816448
Brief Title
Effects of Sub-Occipital Myofascial Release in Patients With Cervicogenic Headache
Official Title
Effects of Sub-Occipital Myofascial Release in Patients With Cervicogenic Headache
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cervicogenic headache is a secondary form of headache that occurs from the upper cervical spine and atlanto-occipital joint. A CGH is a frequent source of chronic headache and is frequently misdiagnosed .Cervicogenic headache is among the most common problem affecting four times more women as compared to males and is considered by some painful feeling in the head , neck ,temporal area, frontal area and around the eyes areas.
Detailed Description
There is also pain in the face and ipsilateral head that does not alternate the sides, but when cervicogenic headache becomes severe, in some patients pain may occasionally feel it on the other side of the head. Diagnosis of cervicogenic headache depends on the detailed patient's history, manual examination and the assessment of nervous system. After the diagnostic block test disappearance of headache shows that the source of this pain is cervical spine. Cervical flexion rotation test is a very useful diagnostic measure in cervical movement restriction and differential diagnosis of cervicogenic headache. Physical therapy is considered most effective treatment of cervicogenic headache in which different techniques manipulative therapy, mobilization of cervical vertebrae, stretches and sub-occipital myofascial release used. Objective: To determine the effects of sub-occipital myofascial release in patients with cervicogenic headache. Methods: This study was randomized control trial and on the basis of inclusion criteria, 22 patients were included and were randomized through sealed envelope in two groups A and B. Group A was given sub-occipital myofascial release along with conventional therapy while group B was given cervical mobilization and conventional therapy and both groups were assessed by using Neck Disability Index(NDI), Pain Numerical Rating Scale(PNRS) and cervical range of motion by goniometer at baseline, Week(1-4) and 8th week( last week) .The data was analyzed using SPSS 21.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache
Keywords
Cervicogenic headache, Pain Numerical Rating Scale, Neck disability index

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Studygroup
Arm Type
Experimental
Arm Description
cervical mobilization (Headache SNAG) with baseline treatment (Hot pack for 10 minutes, TENS 10 minutes, Neck isometrics and stretching).
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Sub-occipital myofascial release with baseline treatment (Hot pack for 10 minutes, TENS for 10 minutes, Neck isometrics and stretching
Intervention Type
Other
Intervention Name(s)
cervical mobilization (Headache SNAG)
Intervention Description
For cervical mobilization the patient's position is sitting on a chair in the erect posture. The therapist handled C2 spinous process with the middle phalanx of one hand. With the other hand, he performed ventral glide asked the patient to move neck in all directions (Flexion, Extension, Side bending and rotation) one by one and then slowly move the neck back to its starting position while the therapist maintained the ventral glide.
Intervention Type
Other
Intervention Name(s)
Sub-occipital myofascial release
Intervention Description
For the application of the technique , the patient position is supine lying with the head fully supported on therapist's hands and therapist places 3 middle fingers just inferior to the nuchal line, lifts the fingers tips towards the ceiling while resting the head on the table and then therapist will apply a gentle upward pull. This procedure done for 2 to 3 minutes and 5 to 7 repetitions, 3 sessions per week on alternate days were given for 6 weeks. Evaluation was done before treatment, during treatment at 4th week and after treatment at 6th week. Outcomes will be measured by NDI, PNRS and Universal Goniometer.
Primary Outcome Measure Information:
Title
Pain Numeric Rating Scale
Description
Pain Numeric Rating Scale (PNRS) scores in subjects with moderate/severe pain at baseline. *P < 0.0001 vs. baseline. Includes only subjects with baseline PNRS score of 4 to 10. Scale ranges from 0 to 10.
Time Frame
4 months
Title
NECK DISABILITY INDEX
Description
the overall score range is between 0 and 50, 0 being no to little pain and discomfort while 50 being the severest degree of pain and disability with complete activity limitation.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Both Genders Age between 20 to 75 Years Neck pain referring the unilateral pain to the sub-occipital region and head. Headache intensifying upon manual pressure to upper cervical joints and muscles With the cranio-cervical Flexion rotation exam, neck pain and ipsilateral headache and restriction of C1 and C2 rotation. Exclusion Criteria: • Tension headache (Headache on both sides) If the patient not tolerate the cranio-cervical Flexion rotation test. Patients presents with autonomic symptoms like visual disturbance, vertigo, dizziness. If the physiotherapeutic modalities used for head pain in the last 6 months. Headache other than cervical origins. Clinically diagnosed as case of cervical radiculopathy or myelopathy. Extreme cervical discomfort due to disk herniation, stenosis of the spinal canal and cervical arthritis. Each other disorder that may be contraindicated in the upper cervical area of myofascial release.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryam Shabbir, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah Rehabilitation Center
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Singh LR, Chauhan V. Comparison of efficacy of myofascial release and positional release therapy in tension type headache. JMSCR. 2014;2(9):2372-9.
Results Reference
background
PubMed Identifier
24421621
Citation
Racicki S, Gerwin S, Diclaudio S, Reinmann S, Donaldson M. Conservative physical therapy management for the treatment of cervicogenic headache: a systematic review. J Man Manip Ther. 2013 May;21(2):113-24. doi: 10.1179/2042618612Y.0000000025.
Results Reference
background
PubMed Identifier
15928349
Citation
Biondi DM. Cervicogenic headache: a review of diagnostic and treatment strategies. J Am Osteopath Assoc. 2005 Apr;105(4 Suppl 2):16S-22S.
Results Reference
background
PubMed Identifier
21125430
Citation
Antonaci F, Sjaastad O. Cervicogenic headache: a real headache. Curr Neurol Neurosci Rep. 2011 Apr;11(2):149-55. doi: 10.1007/s11910-010-0164-9.
Results Reference
background
PubMed Identifier
10668109
Citation
Fredriksen TA, Salvesen R, Stolt-Nielsen A, Sjaastad O. Cervicogenic headache: long-term postoperative follow-up. Cephalalgia. 1999 Dec;19(10):897-900. doi: 10.1046/j.1468-2982.1999.1910897.x.
Results Reference
background
PubMed Identifier
11403743
Citation
Bogduk N. Cervicogenic headache: anatomic basis and pathophysiologic mechanisms. Curr Pain Headache Rep. 2001 Aug;5(4):382-6. doi: 10.1007/s11916-001-0029-7.
Results Reference
background
PubMed Identifier
1408296
Citation
Bovim G, Berg R, Dale LG. Cervicogenic headache: anesthetic blockades of cervical nerves (C2-C5) and facet joint (C2/C3). Pain. 1992 Jun;49(3):315-320. doi: 10.1016/0304-3959(92)90237-6.
Results Reference
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Effects of Sub-Occipital Myofascial Release in Patients With Cervicogenic Headache

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